Quality Assurance Engineer - Medical Devices
A specialist Medical Devices company are currently recruiting a Quality Assurance Engineer to join their hugely successful Quality Assurance (QA) Team at their site in Hertfordshire, UK. This leading manufacturer is the largest orthopaedic organisation in the UK as well as many worldwide countries.
They are renowned for their manufacture of high class Orthopeadic Devices. This is one of the UK fastest growing Medical Devices organisations winning many awards for science and research. This is an exceptional opportunity for a Quality Engineer to expand and develop their experience in all aspects of Quality Assurance and you will report directly to the Quality Assurance Manager with the following responsibilities:
Key Responsibilities will include: delivering Quality Assurance, review, approve and manage documents i.e. validation protocols and SOPs along with supporting the risk management and Design control for the production of new and existing Medical Device products. You will also be responsible for providing technical assistance and review quality plans for the company. Participate in process evaluations where necessary, providing technical assessment, history files/CAPA Processes, complaint investigations, dealing with legal compliance and perform calibration reviews for test equipment adhering to the company's high standards.
For this position, you will have gained substantial experience in Quality assurance in the Medical Devices industry with ISO 13485 experience. You should have experience in manufacturing, good manufacturing practice (GMP), Quality systems management (QMS), FDA Complaints Systems, Applications of design control. Additionally, experience or training as ISO 14971 would be highly beneficial.
This is a fantastic unique opportunity offering a competitive salary package, along with a number of benefits such as life assurance, pension and a generous holiday entitlement.
For further information on this role or company as well as other Quality Engineering job opportunities, please contact myself, Ekta Multani at Paramount Recruitment on 0121 616 3474.
Keywords: Quality Assurance, Quality Assurance Engineer, Medical Devices, ISO 9001, ISO 13485, SOUTH EAST , CAPA, Design, 21 CFR part 820, Six Sigma, LEAN, GMP, PFMEA, Quality Engineering Manager, Compliance, Validation , Quality Assurance Design Jobs, FDA, MHRA, GMP, FDA, SOPs, ISO 14971.
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